Merck adds another OK to Keytruda scoreboard; Ardelyx, Kyowa Kirin broadens partnership beyond tenapanor
→ Merck‘s anti-PD-1 blockbuster, Keytruda, is racking up win after win. The newest jewel to the crown for the company is the Chinese approval of the therapy in combination with carboplatin and paclitaxel for the first-line cases of metastatic squamous non-small cell lung cancer (NSCLC). With this new indication, Keytruda is now approved to treat both squamous and non-squamous NSCLC in conjunction with chemotherapy, as well as a subgroup of NSCLC patients as a monotherapy.
→ After recently receiving its first FDA OK for IBS and on the back of two successful Phase III trials, Ardelyx announced that it will be expanding its partnership with Kyowa Kirin. The expansion builds on a 2017 pact that allows the Japanese pharma to develop and commercialize tenapanor, now Ibsrela in the US, in cardiorenal diseases including hyperphosphatemia. Kyowa Kirin is now paying Ardelyx $10 million more to leverage its discovery platform against two undisclosed targets, with up to $10.5 million in upfront $500 million in milestones ayable should they exercise the option to license these compounds. In a second agreement, it’s injecting $20 million into the Fremont, CA-based biotech in an equity investment valuing its shares at $6.96.
→ Looks like Merck wasn’t the only one to snag a China approval. Astellas announced today that Xtandi — the drug its partner Pfizer grabbed in the $14 billion acquisition of Medivation — has gotten the green light for the treatment of adult men with metastatic castration-resistant prostate cancer who have failed androgen deprivation therapy and not received chemotherapy. Xtandi is a growing franchise for the duo, who are still seeking label expansions in the US.
→ After pushing their co-founder out because of an HR violation, Revance Therapeutics — focused on the development of neuromodulator products for aesthetic and therapeutic indications — is forging ahead to seek approval for its Botox rival DaxibotulinumtoxinA for Injection (DAXI) to treat moderate to severe frown lines. The company submitted a BLA to the FDA based on SAKURA Phase III trials, anticipating a potential OK in the second half of 2020.
→ Teva, the world’s largest manufacturer of generic drugs, has inked two research deals with institutions in its native Israel. One pact is with the Weizmann Institute of Science‘s commercial arm, Yeda Research and Development and the other, an expansion on their scientific collaboration with Tel Aviv University. The work with Yeda Research aims at identifying the next generation of antibodies for cancer treatment, while the partnership with Tel Aviv will focus on research within the fields of cancer and brain studies.